510(k) K250646

Impact PEEK Union Nail System by Nvision Biomedical Technologies — Product Code HTY

K250646 is an FDA 510(k) premarket notification submitted by Nvision Biomedical Technologies for the device "Impact PEEK Union Nail System". The FDA issued a decision of Substantially Equivalent on June 11, 2025. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Nvision Biomedical Technologies has at least 10 other 510(k) clearances on record.